Section B Changed Classes/Guidelines Final
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Table S1: Sensitivity, Specificity, PPV, NPV, and F1 Score of NLP Vs. ICD for Identification of Symptoms for (A) Biome Developm
Table S1: Sensitivity, specificity, PPV, NPV, and F1 score of NLP vs. ICD for identification of symptoms for (A) BioMe development cohort; (B) BioMe validation cohort; (C) MIMIC-III; (D) 1 year of notes from patients in BioMe calculated using manual chart review. A) Fatigue Nausea and/or vomiting Anxiety Depression NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.99 (0.93- 0.59 (0.43- <0.00 0.25 (0.12- <0.00 <0.00 0.54 (0.33- Sensitivity 0.99 (0.9 – 1) 0.98 (0.88 -1) 0.3 (0.15-0.5) 0.85 (0.65-96) 0.02 1) 0.73) 1 0.42) 1 1 0.73) 0.57 (0.29- 0.9 (0.68- Specificity 0.89 (0.4-1) 0.75 (0.19-1) 0.68 0.97 (0.77-1) 0.03 0.98 (0.83-1) 0.22 0.81 (0.53-0.9) 0.96 (0.79-1) 0.06 0.82) 0.99) 0.99 (0.92- 0.86 (0.71- 0.94 (0.79- 0.79 (0.59- PPV 0.96 (0.82-1) 0.3 0.95 (0.66-1) 0.02 0.95 (0.66-1) 0.16 0.93 (0.68-1) 0.12 1) 0.95) 0.99) 0.92) 0.13 (0.03- <0.00 0.49 (0.33- <0.00 0.66 (0.48- NPV 0.89 (0.4-1) 0.007 0.94 (0.63-1) 0.34 (0.2-0.51) 0.97 (0.81-1) 0.86 (0.6-0.95) 0.04 0.35) 1 0.65) 1 0.81) <0.00 <0.00 <0.00 F1 Score 0.99 0.83 0.88 0.57 0.95 0.63 0.82 0.79 0.002 1 1 1 Itching Cramp Pain NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.98 (0.86- 0.24 (0.09- <0.00 0.09 (0.01- <0.00 0.52 (0.37- <0.00 Sensitivity 0.98 (0.85-1) 0.99 (0.93-1) 1) 0.45) 1 0.29) 1 0.66) 1 0.89 (0.72- 0.5 (0.37- Specificity 0.96 (0.8-1) 0.98 (0.86-1) 0.68 0.98 (0.88-1) 0.18 0.5 (0-1) 1 0.98) 0.66) 0.88 (0.69- PPV 0.96 (0.8-1) 0.8 (0.54-1) 0.32 0.8 (0.16-1) 0.22 0.99 (0.93-1) 0.98 (0.87-1) NA* 0.97) 0.98 (0.85- 0.57 (0.41- <0.00 0.58 (0.43- <0.00 NPV 0.98 (0.86-1) 0.5 (0-1) 0.02 (0-0.08) NA* 1) 0.72) 1 0.72) 1 <0.00 <0.00 <0.00 F1 Score 0.97 0.56 0.91 0.28 0.99 0.68 1 1 1 *Denotes 95% confidence intervals and P values that could not be calculated due to insufficient cells in 2x2 tables. -
Palliative Care Case of the Month
PALLIATIVE CARE CASE OF THE MONTH “Treating Non-Infectious Diarrhea” by Robert Arnold, MD Volume 19, No. 98 August, 2019 Case 1: Mr. Jones is a 58-year-old man with short gut Three drugs are used because of their ability to slow down the syndrome. Palliative Care was consulted for goals of care, gut, allowing for more time for absorption of intestinal fluids a however quickly it became clear uncontrolled diarrhea was a decrease of diarrhea. The most well-know is loperamide, a larger priority. He said having to change the bag every few hours synthetic opiate which has minimal absorption. The dosing is 4 completely interfered with his living a normal life. He said, “I’d mg after one’s first bowel movement and then 2 mg after every rather die than have all of this diarrhea.” unformed stool, up to 16 mg (in palliative care patients there is some data for use up to 54 mg).9, 10 Loperamide should be Case 2: A 62-year-old woman with non-small cell lung cancer continued for 12 hours after diarrhea is stopped. Adverse effects is receiving immunotherapy. She has done quite well but is include mostly constipation, abdominal cramps, nausea and distressed by her diarrhea. She tried Lomotil and Imodium but rarely CNS effects like fatigue or dizziness. Cases of torsades de neither worked. When seeing her palliative care doctor, she said, pointes and death have been reported with higher than “It isn’t worth treating my cancer if I can’t live a normal life.” 9 recommended doses. -
(12) United States Patent (10) Patent No.: US 9,498,481 B2 Rao Et Al
USOO9498481 B2 (12) United States Patent (10) Patent No.: US 9,498,481 B2 Rao et al. (45) Date of Patent: *Nov. 22, 2016 (54) CYCLOPROPYL MODULATORS OF P2Y12 WO WO95/26325 10, 1995 RECEPTOR WO WO99/O5142 2, 1999 WO WOOO/34283 6, 2000 WO WO O1/92262 12/2001 (71) Applicant: Apharaceuticals. Inc., La WO WO O1/922.63 12/2001 olla, CA (US) WO WO 2011/O17108 2, 2011 (72) Inventors: Tadimeti Rao, San Diego, CA (US); Chengzhi Zhang, San Diego, CA (US) OTHER PUBLICATIONS Drugs of the Future 32(10), 845-853 (2007).* (73) Assignee: Auspex Pharmaceuticals, Inc., LaJolla, Tantry et al. in Expert Opin. Invest. Drugs (2007) 16(2):225-229.* CA (US) Wallentin et al. in the New England Journal of Medicine, 361 (11), 1045-1057 (2009).* (*) Notice: Subject to any disclaimer, the term of this Husted et al. in The European Heart Journal 27, 1038-1047 (2006).* patent is extended or adjusted under 35 Auspex in www.businesswire.com/news/home/20081023005201/ U.S.C. 154(b) by Od en/Auspex-Pharmaceuticals-Announces-Positive-Results-Clinical M YW- (b) by ayS. Study (published: Oct. 23, 2008).* This patent is Subject to a terminal dis- Concert In www.concertpharma. com/news/ claimer ConcertPresentsPreclinicalResultsNAMS.htm (published: Sep. 25. 2008).* Concert2 in Expert Rev. Anti Infect. Ther. 6(6), 782 (2008).* (21) Appl. No.: 14/977,056 Springthorpe et al. in Bioorganic & Medicinal Chemistry Letters 17. 6013-6018 (2007).* (22) Filed: Dec. 21, 2015 Leis et al. in Current Organic Chemistry 2, 131-144 (1998).* Angiolillo et al., Pharmacology of emerging novel platelet inhibi (65) Prior Publication Data tors, American Heart Journal, 2008, 156(2) Supp. -
Anti-Diarrheal Activity and Brine Shrimp Lethality Bioassay of Methanolic Extract of Cordyline Fruticosa (L.) A
Naher et al. Clinical Phytoscience (2019) 5:15 https://doi.org/10.1186/s40816-019-0109-z ORIGINAL CONTRIBUTION Open Access Anti-diarrheal activity and brine shrimp lethality bioassay of methanolic extract of Cordyline fruticosa (L.) A. Chev. leaves Sharmin Naher1*, Md. Abdullah Aziz1, Mst. Irin Akter2, S. M. Mushiur Rahman1, Sadiur Rahman Sajon1 and Kishor Mazumder1,3 Abstract Background: Cordyline fruticosa (L.) A. Chev. (Asparagaceae) is a plant which is traditionally used for the treatment of cough, bloody cough, diarrhea, dysentery, high fever, difficulties in urine, bloody urine, small pox, madness, skin eruptions, joint pains, rheumatic bone pains, sore throat, neck pain, bleeding hemorrhoids and inflammation in the digestive tract. Therefore, the present work aims to investigate the antidiarrheal and cytotoxic activities of methanolic extract of Cordyline fruticosa leaves in mice and brine shrimp, respectively. Methods: The effects of the methanol extract of Cordyline fruticosa leaves (MCFL) on castor oil-induced diarrhea, magnesium sulphate induced diarrhea and charcoal meal test in mice were investigated. In addition, brine shrimp lethality bioassay method was used to evaluate cytotoxic activity of MCFL. Results: In castor oil induced diarrheal test, MCFL at the dose of 200, 400 and 800 mg/kg body weight significantly (∗P< 0.05, versus control) and dose-dependently reduced the frequency of diarrhea. The frequency of magnesium sulphate-induced diarrhea was significantly reduced by MCFL at the dose of with 800 mg/kg. In the charcoal meal test, the extract at the dose of 400 and 800 mg/kg body weight significantly (∗P< 0.05) reduced the distance travelled by charcoal along the intestinal tract when compare with control. -
Human Cytogenetics Prenatal Diagnostics
Cytogenetics Human Cytogenetics Prenatal Diagnostics Optimized Medium for Culture and Genetic Analysis of Human Amniotic Fluid Cells BIOAMF-1 and Chorionic Villi ( CV ) Samples Basal Medium and Supplement Chromosome Karyotyping was first developed in the BIOAMF-1 is designed for the primary culture of field of Cytogenetics. human amniotic fluid cells and chorionic villi (CV) The basic principle of the method is the preparation samples in both open (5% CO2) and closed systems. of chromosomes for microscopic observation by The medium allows rapid growth of amniocytes or arresting cell mitosis at metaphase with colchicine and treating the cells with a hypotonic solution. This chorionic villi for use in karyotyping. is followed by regular or fluorescent staining of the No supplementation with serum or serum- chromosomes, which are then tested with the aid of a substitutes is necessary. microscope and computer programs to arrange and The medium consists of two components: basal identify the chromosomes for the presence of genetic medium and frozen supplements. abnormalities. In principle, this method enables the identification Instructions for Use of any abnormality - excess chromosomes or For the preparation of 500ml complete medium, use chromosome deficiency, broken chromosomes, 01-190-1A with 01-192-1E. or excess genetic material (as a result of a For the preparation of 100ml complete medium, use recombination process). 01-190-1B with 01-192-1D. Clinical cytogenetics laboratories use this method Thaw the BIOAMF-1 Supplement by swirling in a with amniotic fluid, chorionic villi, blood cells, skin cells, and so on, which can be cell cultured to obtain 37ºC water bath, and transfer the contents to the mitotic cells. -
Product List March 2019 - Page 1 of 53
Wessex has been sourcing and supplying active substances to medicine manufacturers since its incorporation in 1994. We supply from known, trusted partners working to full cGMP and with full regulatory support. Please contact us for details of the following products. Product CAS No. ( R)-2-Methyl-CBS-oxazaborolidine 112022-83-0 (-) (1R) Menthyl Chloroformate 14602-86-9 (+)-Sotalol Hydrochloride 959-24-0 (2R)-2-[(4-Ethyl-2, 3-dioxopiperazinyl) carbonylamino]-2-phenylacetic 63422-71-9 acid (2R)-2-[(4-Ethyl-2-3-dioxopiperazinyl) carbonylamino]-2-(4- 62893-24-7 hydroxyphenyl) acetic acid (r)-(+)-α-Lipoic Acid 1200-22-2 (S)-1-(2-Chloroacetyl) pyrrolidine-2-carbonitrile 207557-35-5 1,1'-Carbonyl diimidazole 530-62-1 1,3-Cyclohexanedione 504-02-9 1-[2-amino-1-(4-methoxyphenyl) ethyl] cyclohexanol acetate 839705-03-2 1-[2-Amino-1-(4-methoxyphenyl) ethyl] cyclohexanol Hydrochloride 130198-05-9 1-[Cyano-(4-methoxyphenyl) methyl] cyclohexanol 93413-76-4 1-Chloroethyl-4-nitrophenyl carbonate 101623-69-2 2-(2-Aminothiazol-4-yl) acetic acid Hydrochloride 66659-20-9 2-(4-Nitrophenyl)ethanamine Hydrochloride 29968-78-3 2,4 Dichlorobenzyl Alcohol (2,4 DCBA) 1777-82-8 2,6-Dichlorophenol 87-65-0 2.6 Diamino Pyridine 136-40-3 2-Aminoheptane Sulfate 6411-75-2 2-Ethylhexanoyl Chloride 760-67-8 2-Ethylhexyl Chloroformate 24468-13-1 2-Isopropyl-4-(N-methylaminomethyl) thiazole Hydrochloride 908591-25-3 4,4,4-Trifluoro-1-(4-methylphenyl)-1,3-butane dione 720-94-5 4,5,6,7-Tetrahydrothieno[3,2,c] pyridine Hydrochloride 28783-41-7 4-Chloro-N-methyl-piperidine 5570-77-4 -
WITHOUTUS010307409B2 (12 ) United States Patent ( 10 ) Patent No
WITHOUTUS010307409B2 (12 ) United States Patent ( 10 ) Patent No. : US 10 , 307 ,409 B2 Chase et al. (45 ) Date of Patent: Jun . 4 , 2019 ( 54 ) MUSCARINIC COMBINATIONS AND THEIR (52 ) U . S . CI. USE FOR COMBATING CPC . .. .. A61K 31/ 4439 (2013 . 01 ) ; A61K 9 /0056 HYPOCHOLINERGIC DISORDERS OF THE (2013 . 01 ) ; A61K 9 / 7023 ( 2013 . 01 ) ; A61K CENTRAL NERVOUS SYSTEM 31 / 166 ( 2013 . 01 ) ; A61K 31 / 216 ( 2013 . 01 ) ; A61K 31 /4178 ( 2013 .01 ) ; A61K 31/ 439 (71 ) Applicant: Chase Pharmaceuticals Corporation , ( 2013 .01 ) ; A61K 31 /44 (2013 . 01 ) ; A61K Washington , DC (US ) 31/ 454 (2013 .01 ) ; A61K 31/ 4725 ( 2013 .01 ) ; A61K 31 /517 (2013 .01 ) ; A61K 45 / 06 ( 72 ) Inventors : Thomas N . Chase , Washington , DC (2013 . 01 ) (US ) ; Kathleen E . Clarence -Smith , ( 58 ) Field of Classification Search Washington , DC (US ) CPC .. A61K 31/ 167 ; A61K 31/ 216 ; A61K 31/ 439 ; A61K 31 /454 ; A61K 31 /4439 ; A61K (73 ) Assignee : Chase Pharmaceuticals Corporation , 31 /4175 ; A61K 31 /4725 Washington , DC (US ) See application file for complete search history. ( * ) Notice : Subject to any disclaimer, the term of this (56 ) References Cited patent is extended or adjusted under 35 U . S . C . 154 (b ) by 0 days . U . S . PATENT DOCUMENTS 5 ,534 ,520 A 7 / 1996 Fisher et al. ( 21) Appl . No. : 15 /260 , 996 2008 /0306103 Al 12 /2008 Fisher et al. 2011/ 0021503 A1* 1/ 2011 Chase . .. A61K 31/ 27 ( 22 ) Filed : Sep . 9 , 2016 514 / 215 2011/ 0071135 A1 * 3 / 2011 Chase . .. .. .. A61K 31/ 166 (65 ) Prior Publication Data 514 / 215 2011 /0245294 Al 10 / 2011 Paborji et al. -
(12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 De Juan Et Al
US 200601 10428A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0110428A1 de Juan et al. (43) Pub. Date: May 25, 2006 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA (US); A6F 2/00 (2006.01) Signe E. Varner, Los Angeles, CA (52) U.S. Cl. .............................................................. 424/427 (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Correspondence Address: Featured is a method for instilling one or more bioactive SCOTT PRIBNOW agents into ocular tissue within an eye of a patient for the Kagan Binder, PLLC treatment of an ocular condition, the method comprising Suite 200 concurrently using at least two of the following bioactive 221 Main Street North agent delivery methods (A)-(C): Stillwater, MN 55082 (US) (A) implanting a Sustained release delivery device com (21) Appl. No.: 11/175,850 prising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more (22) Filed: Jul. 5, 2005 bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more Related U.S. Application Data bioactive agents Subretinally; and (60) Provisional application No. 60/585,236, filed on Jul. (C) instilling (e.g., injecting or delivering by ocular ion 2, 2004. Provisional application No. 60/669,701, filed tophoresis) one or more bioactive agents into the Vit on Apr. 8, 2005. reous humor of the eye. Patent Application Publication May 25, 2006 Sheet 1 of 22 US 2006/0110428A1 R 2 2 C.6 Fig. -
Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
(12) United States Patent (10) Patent No.: US 8,999,632 B2 Falcon Et Al
US008.999632B2 (12) United States Patent (10) Patent No.: US 8,999,632 B2 Falcon et al. (45) Date of Patent: Apr. 7, 2015 (54) METHOD FOR MEASURING ATR (52) U.S. Cl. INHIBITION MEDIATED INCREASES IN DNA CPC ............ G0IN33/5047 (2013.01); G0IN33/68 DAMAGE (2013.01) (58) Field of Classification Search (71) Applicants: Vertex Pharmaceuticals Incorporated, USPC ........................................................ 435/2, 15 Cambridge, MA (US); University of See application file for complete search history. Newcastle Upon Tyne, Newcastle Upon Tyne (GB) (56) References Cited (72) Inventors: Susanna Falcon, Newbury (GB); Philip PUBLICATIONS Reaper, Shillingford (GB); John Kao et al. Inhibition of Gamma-H2AXAfter Ionizing Radiation. As a Pollard, Abingdon (GB); Nicola Curtin, Biological Surrogate of Impaired Upstream DNA Damage Signaling Newcastle upon Tyne (GB); Fiona and Radiosensitivity; Journal of Cancer Molecules, vol. 5, No. 2 Middleton, South Gosforth (GB); Tao (2010) pp. 49-54.* Chen, Suzhou (CN) Buscemi, G., et al., “DNA Damage-Induced Cell Cycle Regulation of Novel Chk2 Phosphoresidues'. Molecular and Cellular Biology, (73) Assignee: Vertex Pharmaceuticals Incorporated, 26(21), (2006), pp. 7832-7845 (DOI: 10.1128/MCB.00534-06). Boston, MA (US) Chen, T., et al., “Targeting the S and G2 checkpoint to treat cancer. s Drug Discovery Today, 17(5/6), (2012), pp. 194-202, (DOI: 10.1016/ - r - j.drudis.2011, 12.009). (*) Notice: Subject to any disclaimer, the term of this Chen, T., et al., “Development of a biomarker of ATR activity in patent is extended or adjusted under 35 surrogate human tissues”, Newcastle University, Poster, Nov. 2012. U.S.C. 154(b) by 0 days. -
(200731) Hypromellose Phthalate (220824) Ibudilast
21222122 Infrared Reference Spectra JP XVII Hypromellose Phthalate (200731) Hypromellose Phthalate (220824) Ibudilast The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. (See the General Notices 5.) JP XVII Infrared Reference Spectra 21232123 Ibuprofen Ibuprofen Piconol Ifenprodil Tartrate The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. (See the General Notices 5.) 21242124 Infrared Reference Spectra JP XVII Imidapril Hydrochloride Imipenem Hydrate Indapamide The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. (See the General Notices 5.) JP XVII Infrared Reference Spectra 21252125 Indenolol Hydrochloride Indometacin Iohexol The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. (See the General Notices 5.) 21262126 Infrared Reference Spectra JP XVII Iopamidol Iotalamic Acid Iotroxic Acid The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. -
Functional Genomics Approaches to Elucidate Vulnerabilities of Intrinsic and Acquired Chemotherapy Resistance
cells Review Functional Genomics Approaches to Elucidate Vulnerabilities of Intrinsic and Acquired Chemotherapy Resistance Ronay Cetin 1,† , Eva Quandt 2,† and Manuel Kaulich 1,3,4,* 1 Institute of Biochemistry II, Goethe University Frankfurt-Medical Faculty, University Hospital, 60590 Frankfurt am Main, Germany; [email protected] 2 Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain; [email protected] 3 Frankfurt Cancer Institute, 60596 Frankfurt am Main, Germany 4 Cardio-Pulmonary Institute, 60590 Frankfurt am Main, Germany * Correspondence: [email protected]; Tel.: +49-(0)-69-6301-5450 † These authors contributed equally to this work. Abstract: Drug resistance is a commonly unavoidable consequence of cancer treatment that results in therapy failure and disease relapse. Intrinsic (pre-existing) or acquired resistance mechanisms can be drug-specific or be applicable to multiple drugs, resulting in multidrug resistance. The presence of drug resistance is, however, tightly coupled to changes in cellular homeostasis, which can lead to resistance-coupled vulnerabilities. Unbiased gene perturbations through RNAi and CRISPR technologies are invaluable tools to establish genotype-to-phenotype relationships at the genome scale. Moreover, their application to cancer cell lines can uncover new vulnerabilities that are associated with resistance mechanisms. Here, we discuss targeted and unbiased RNAi and CRISPR efforts in the discovery of drug resistance mechanisms by focusing on first-in-line chemotherapy and their enforced vulnerabilities, and we present a view forward on which measures should be taken to accelerate their clinical translation. Citation: Cetin, R.; Quandt, E.; Kaulich, M. Functional Genomics Keywords: chemotherapy resistance; cancer and drug vulnerabilities; functional genomics; RNAi Approaches to Elucidate Vulnerabilities of Intrinsic and and CRISPR screens Acquired Chemotherapy Resistance.